Nitrous Oxide- Suicidal Ideation
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD), Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/11/2018 |
| Start Date: | October 30, 2018 |
| End Date: | December 2021 |
Adjunctive Nitrous Oxide for Acute Suicidal Ideation in Unipolar Depressed Hospitalized Patients
Most clinical major depression responds to standard treatments (medication and
psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond
to these treatments and are referred to as treatment-resistant major depression (TRMD). New
treatments for TRMD are needed, and one promising line of research are drugs known as
N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, the
investigators of this study demonstrated that the NMDA antagonist nitrous oxide is effective
in TRMD, reducing depressive symptoms, guilt, and suicidal thinking.
To more closely investigate suicidal thinking, this study is designed as a double-blind,
randomized, prospective, inpatient trial comparing inhaled nitrous oxide (N2O) plus treatment
as usual versus inhaled placebo plus treatment as usual. All unipolar depressed, acutely
suicidal inpatients will receive standard treatment for their depression/ suicidal thinking
(TAU). Additionally, participants will undergo a maximum of four one hour inhalation sessions
as inpatients and 2 booster sessions as outpatients during which they will receive either
inhaled nitrous oxide (50% nitrous oxide/50% oxygen = active treatment) or placebo gas (50%
nitrogen/50% oxygen). A target total of 50 patients with suicidal ideation and unipolar
depression will be enrolled, 25 of whom will be assigned to the TAU control group and 25 of
whom will be assigned to the N2O + TAU experimental group.
psychotherapy); however, a significant subset of depressed patients (15-20%) do not respond
to these treatments and are referred to as treatment-resistant major depression (TRMD). New
treatments for TRMD are needed, and one promising line of research are drugs known as
N-methyl-D-aspartate (NMDA) glutamate receptor antagonists. In a recent pilot study, the
investigators of this study demonstrated that the NMDA antagonist nitrous oxide is effective
in TRMD, reducing depressive symptoms, guilt, and suicidal thinking.
To more closely investigate suicidal thinking, this study is designed as a double-blind,
randomized, prospective, inpatient trial comparing inhaled nitrous oxide (N2O) plus treatment
as usual versus inhaled placebo plus treatment as usual. All unipolar depressed, acutely
suicidal inpatients will receive standard treatment for their depression/ suicidal thinking
(TAU). Additionally, participants will undergo a maximum of four one hour inhalation sessions
as inpatients and 2 booster sessions as outpatients during which they will receive either
inhaled nitrous oxide (50% nitrous oxide/50% oxygen = active treatment) or placebo gas (50%
nitrogen/50% oxygen). A target total of 50 patients with suicidal ideation and unipolar
depression will be enrolled, 25 of whom will be assigned to the TAU control group and 25 of
whom will be assigned to the N2O + TAU experimental group.
Inclusion Criteria:
1. Patients aged 18-65 years old;
2. current diagnosis of unipolar, major depressive disorder (MDD) without psychosis as
defined by the Mini-International Neuropsychiatric Interview (MINI) and The Fourth
Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) DSM-IV
determined by clinical interview and by a baseline score of ≥18 on the HDRS-21
(Hamilton Depression Rating Scale 21-item;
3. moderate to severe SI defined as a score ≥3 on the HDRS-21 suicide item (item #3);
4. will have good command of the English language;
5. will have been voluntarily admitted to the inpatient Psychiatric Units at
Barnes-Jewish Hospital/Washington University in St. Louis, MO.
Exclusion Criteria:
1. Lifetime DSM-IV (obtained via MINI) diagnoses of schizophrenia, schizoaffective
disorders, bipolar disorder, obsessive-compulsive disorder, evidence of severe
personality disorder (e.g., history of recurrent self-mutilation/cutting, significant
and recurrent tumultuous relationships), and panic disorders;
2. past 12-month substance abuse/dependence other than nicotine;
3. active psychotic symptoms;
4. significant pulmonary disease and/or requiring supplemental oxygen;
5. administration of other N-Methyl-D-aspartate (NMDA)-receptor antagonist treatment
(e.g., ketamine) within two weeks of entry into study;
6. currently receiving electroconvulsive therapy;
7. contraindications for nitrous oxide (pneumothorax, bowel obstruction, middle ear
occlusion, elevated intracranial pressure, chronic cobalamin and/or folate deficiency
treated with folic acid or vitamin B12);
8. past 12-month history of head trauma;
9. women who are pregnant or breastfeeding;
10. any other factor that in the investigators' judgment may affect patient safety or
compliance.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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